WALLSTENT® Endoprosthesis H965404110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729204060), received between Mar 30, 2018 and Aug 14, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. A 18 X 40/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT STENT WAS DEPLOYED ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8894234 ↗
• InjuryJul 18, 2019Mechanical Problem; Material Deformation; Activation Failure; Mechanical Problem; Material Deformation; Activation Failure

  IT WAS REPORTED THAT STENT EXPANSION, STENT RECAPTURE DIFFICULTIES AND STENT DAMAGED WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A DEEP VEIN THROMBOSIS, A 18X40/10FR UNI PLUS 75CM WALLSTENT UNI STENT CATHETER WAS ADVANCED TO TREAT THE LESION. THE PHYSICIAN NOTICED THAT THE STENT DID NOT FULLY OPEN. THE STET WAS ATTEMPTED TO BE RECONTRAINED BUT IT WAS NOT ABLE TO BE RECONSTRAINED. THE STENT WAS IMPLANTED AND IT WAS NOTICED UNDER ANGIOGRAPHY THAT THE STENT WAS KINKED. ANOTHER STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8804562 ↗
• MalfunctionMar 30, 2018Difficult to Remove; Difficult to Remove

  SAME CASE AS MDR ID#: 2134265-2018-02331. IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 18X60MM WALLSTENT® ENDOPROSTHESIS STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, THE STENT WAS NOTED TO BE SHORTENED AND HAD TO PLACE ADDITIONAL 18X40 WALLSTENT® ENDOPROSTHESIS STENT. THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, UPON REMOVAL OF THE DELIVERY SYSTEM, RESISTANCE WAS ENCOUNTERED. THE DELIVERY SYSTEM HUNG UP ON THE SHEATH AT THE DISTAL MARKER. THE DEVICE WAS ADVANCED FURTHER INTO THE INFERIOR VENA CAVA AND BACK THROUGH THE SHEATH. DURING THIS TIME, THE DELIVERY SYSTEM BECAME STUCK AT THE PROXIMAL MARKER. EVENTUALLY, THE SHEATH AND THE DELIVERY SYSTEM WAS REMOVED AS A UNIT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT NEGATIVELY AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7385158 ↗